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Human Drugs

Alert on B.Braun Microbore Extension Sets

FDA issues an alert saying B. Braun Medical has notified customers recommending that certain microbore extension sets be removed from the market becau...

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Human Drugs

J&Js Bladder Cancer NDA Gets Priority Review

FDA grants priority review to Johnson & Johnsons NDA for TAR-200 for treating patients with Bacillus Calmette-Gurin-unresponsive high-risk non-muscle ...

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Human Drugs

pCR May Not be Valid Rectal Cancer Endpoint: Study

A Tulane University researcher says FDAs use of pathologic complete response as a surrogate endpoint for rectal cancer treatments is not supported by ...

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Human Drugs

FDA Looking to Expand Project Orbis Outside Oncology

FDA Oncology Center of Excellence director Richard Pazdur says the agency and its international partners are considering expanding Project Orbis from ...

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FDA AI Moves Raise Questions: Attorneys

Three Akin attorneys say regulated industry continues to have questions about FDA actions in launching an internal artificial intelligence tool and ap...

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Human Drugs

Panel Votes Down GSK Multiple Myeloma Drug

FDAs Oncologic Drugs Advisory Committee votes against approving GSKs BLA for Blenrep (belantamab mafodotin) for treating adults with multiple myeloma ...

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Human Drugs

Dexcom Recalls Dexcom Glucose Monitor Receivers

Dexcom recalls certain Dexcom G6, G7, ONE, and ONE+ glucose monitoring receivers because a speaker problem may prevent an alert from sounding.

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Investigate GLP-1 Online Marketing: Blackburn

Sen. Marsha Blackburn and Tennessee attorney general Jonathan Skrmetti call on the Federal Trade Commission to open an investigation into what they sa...

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Medical Devices

Caranx AI Valve Replacement Software Cleared

FDA clears a Caranx Medical 510(k) for its TaviPilot Soft, which the company describes as AI software for real-time intra-operative guidance for trans...

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Human Drugs

Sandoz Recalls Mislabeled Cefazolin for Injection

Sandoz expands a 6/25 recall of cefazolin for injection to include one additional lot after the company received a customer complaint indicating that ...